| CTRI Number |
CTRI/2025/05/087359 [Registered on: 22/05/2025] Trial Registered Prospectively |
| Last Modified On: |
16/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Early Postoperative Ambulation Package] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on the effect of early walking after endonasal surgery on recovery among patients with pituitary region tumors at PGIMER, 2024–2026. |
|
Scientific Title of Study
|
A randomized controlled trial to evaluate the effectiveness of ‘Early postoperative ambulation’ on clinical outcomes and quality of life in patients undergoing endonasal surgery for pituitary region tumors
admitted in Neurosurgical units, PGIMER, Chandigarh, 2024-26. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Rajveer Kaur |
| Designation |
M.Sc. Nursing student |
| Affiliation |
National Institute of Nursing Education, Chandigarh |
| Address |
Department of Nursing, National Institute of Nursing Education, Chandigarh 160012, India
Department of Nursing, National Institute of Nursing Education, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7060480425 |
| Fax |
|
| Email |
rajveerkaur5991@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manju Dhandapani |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Nursing Education, Chandigarh |
| Address |
Department of Nursing, National Institute of Nursing Education, Chandigarh 160012, India
Department of Nursing, National Institute of Nursing Education, Chandigarh 160012, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855151528 |
| Fax |
|
| Email |
manjuseban@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manju Dhandapani |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Nursing Education, Chandigarh |
| Address |
Department of Nursing, National Institute of Nursing Education, Chandigarh 160012, India
Department of Nursing, National Institute of Nursing Education, Chandigarh 160012, India
CHANDIGARH
160012
India |
| Phone |
9855151528 |
| Fax |
|
| Email |
manjuseban@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ms Rajveer Kaur |
| Address |
Department of Nursing, National Institute of Nursing Education, Chandigarh (166012), India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ms Rajveer Kaur |
Nehru Hospital, PGIMER, Chandigarh |
Department of Neurosurgery, Neurosurgical units 3rd floor
Chandigarh
CHANDIGARH |
7060480425
rajveerkaur5991@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh, Institutional Ethics Committee (Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D497||Neoplasm of unspecified behavior of endocrine glands and other parts of nervous system, (2) ICD-10 Condition: G938||Other specified disorders of brain, (3) ICD-10 Condition: G938||Other specified disorders of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Early Postoperative Ambulation Group |
Early Postoperative Ambulation (Key Components)
1. Preoperative
Educate patient on benefits of early ambulation.
Ensure adequate nutrition with dietitian guidance.
2. Immediate Postoperative
Monitor for stability and alertness.
Manage pain using multimodal analgesia.
3. Ambulation
Start once stable; follow structured schedule:
Sit: estimated post operative day 1st as per patients tolerance and ability to move
Ambulate: as per patients recovery and tolerance
Estimated duration of intervention: According to the length of stay of each participant in hospital
|
| Comparator Agent |
Routine Care Group |
Preoperative preparation and post operative pain management, medication adherence and follow up. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients planned for endo nasal surgery for pituitary region tumor who are ambulatory
without support before surgery.
2. Patients willing to participate in study.
3. Patients who undergo a lumbar puncture postoperatively will have early ambulation started
after 12 hours of lumbar puncture. |
|
| ExclusionCriteria |
| Details |
1. Patients who are unconscious.
2. Patients who are intubated beyond 11am on post
operative day 1.
3. Patients who are hemodynamically unstable, whose systolic blood pressure is less than 100 mm Hg.
4.Patients who have lumbar drain during surgery. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| quality of life |
at the end of 1 month after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
clinical outcomes- 1. Headache
2. Post operative complications- CSF rhinorrhea, DVT and others
3. Length of hospital stay |
Post operative day 1, 3, 5, at discharge |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomized controlled trial aims to evaluate the effectiveness of early postoperative ambulation on clinical outcomes and quality of life in patients undergoing endonasal surgery for pituitary region tumors at PGIMER, Chandigarh. A total of 80 adult patients will be selected and randomly allocated using a computer-generated random number table with allocation concealment, assigning 40 participants each to the experimental (early ambulation + routine care) and control (routine care only) groups. Inclusion criteria include adult patients undergoing endonasal surgery who are ambulatory and able to begin walking within 12 hours post-lumbar puncture. Outcome variables include postoperative complications, duration of hospital stay, headache severity, sinus-related quality of life (SNOT-22), and WHOQOL scores. Data will be collected through interviews, clinical records, and standardized tools. Follow-ups will be done on postoperative days 1 to 3 and at discharge, with a final assessment at one month post-surgery. Data will be analyzed using descriptive and inferential statistics. The findings will help support early ambulation practices to enhance recovery and improve the quality of life in neurosurgical patients. |